Special Report: Improving Informed Consent
How you can get people to read the consent form
Experts offer readability advice
Consent forms typically are long, cumbersome, and unfriendly packages that potential study participants might treat like the standard forms they sign at doctor's offices, or worse, like disclaimers to check when installing new software on their computers.
Several informed consent experts have offered these ideas for making the consent documents more accessible, interesting, and readable:
1. Use question and answer format in informed consent document.
In the informed consent document, it's important to give participants signals about where a discussion about a clinical trial is heading, says Steven Joffe, MD, MPH, an ethicist and assistant professor of pediatrics at Dana-Farber Cancer Institute, Children's Hospital Boston.
"If I launch into a discussion of the purpose of a study, they may miss the transition to the purpose of the study," Joffe says. "I need to give them signals of what is happening next."
Providing headings is one way to do this, he notes. "One innovation is to frame the informed consent document as a question and answer. Pose a question the subject ought to be asking and then give the answer."
2. Be sensitive to literacy issues.
Also, clinical trials professionals should be sensitive to literacy problems because people often will hide the fact that they have difficulty with reading, notes Cindy Brach, MPP, senior health policy researcher in the Center for Delivery, Organization, and Markets at the Agency for Healthcare Research and Quality (AHRQ) of Rockville, MD.
"You could say to a participant, 'Would you rather I read the form to you, or would you rather go through it by yourself?'" Brach suggests. "This makes it easy for them to have you read it."
Even people who can read will have difficulty with most consent forms because half of U.S. adults read at or below the eighth grade level, and one third read below the fourth grade level, Brach notes.
"The scoring of grade level is only one measure of readability," Brach says. "It's equally important how it's laid out and how the material is presented."
Another good communication technique is to give people enough time to digest the information you're telling them, Brach says.
"With any research that entails a substantial amount of risk, let them go away, discuss it, and then bring it back to give you an answer," Brach says. "This all has to do with your communicating to them about the research process."
3. Improve the format and structure of the document.
One of the first problems that should be addressed is the actual informed consent form, Brach says. "It often has too small type, it's complex, and it has way too dense information, which is confusing," Brach says.
"Researchers sometimes think they are required to use forms like that because their lawyers think it's what IRBs and the Office for Human Research Protections [OHRP] want," Brach says. "And that's convoluted; it is not a good legal defense to make informed consent forms incomprehensible to research participants."
Some practical advice for improving the informed consent document's structure include the following points:
- Provide one thought or make one point per paragraph. "If you give people two or three thoughts in a graph then you'd be lucky if they come away remembering one of them," Joffe says. "So with each point, present it, tie it up, and move on."
- Include a lot of white space in the document. "If you look at a page of a consent form and it's a wall of text, then that is off-putting even to people with high literacy skills," Joffe says. "So make the pages a lot less intimidating by giving a lot of white space."
- Give more thought to the words you use. "One reason MS Word readability will only get you so far is because it's focused on syllable per word and words per sentence," Joffe says. "So you write shorter words and shorter sentences, but if you are still using words many people don't understand then you haven't completely solved the problem."
- Shorten and simplify the consent form. The Association of American Medical Colleges of Washington, DC, is working on gathering information about consent forms and meeting with experts to assess the current situation and to make plans for effective changes, possibly including providing an example of a shortened consent form, says Howard Dickler, MD, director for clinical research, division of biomedical and health sciences research at AAMC. "We're interested in doing anything we can to make clinical research easier, more effective, and to make human subjects protection better," Dickler says.
- Use larger fonts, bold-faced headings, and bullets within the document's text. "Put information into bite-sized pieces and have a clear heading for paragraphs," Brach suggests. "Use short sentences and common words."
- Some evidence suggests that underlining and capitalizing text does not work well to emphasize things, but bold-faced text does work, Joffe says.
- Improve the standard forms sent out by sponsors. "Some sponsors are willing to work with you if you want to improve their consent form's language," Joffe says. "The answer is for sponsors to send out first rate consent forms in the first place so there isn't a need for each IRB to improve it."
But the ideal situation of having sponsor's consent forms written in plain language is not happening, so it's up to clinical trials professionals to improve these, Joffe adds.
The problem with sponsors' forms is that they sometimes will add language in an effort to minimize liability, and research organizations sometimes do the same thing, Dickler says. "Many times there is a lot of language that pertains to things that are not part of the experiment."
For example, a clinical trial that is testing a new agent, but which includes an arm using standard therapy, might have an informed consent form that discusses side effects from all of the standard therapy agents when these are not new research, Dickler explains. "This adds to the form's length, and it doesn't need to be there, but people get confused about what needs to be there," Dickler says.
5. Use an appendix to place lower priority information.
One useful strategy to make consent forms more readable would be to place some of the necessary information provided by sponsors or required for legal, regulatory purposes at the back of the consent document in the format of an appendix, Joffe suggests.
"Toward the end of the consent form, give it a title that signifies what it is," Joffe says. "Then the information could sit there and be presented in its unfriendly language, but people could choose to read it or not read it."
The consent form would start with the core research consent information, which may be six pages long in quite complicated studies, Joffe says.
"Then there's a signature line, which is preceded by the line, 'I have also received the additional materials that describe the elements of standard care of this study,'" Joffe explains. "And these additional materials are stapled on the back in Appendix A."
An Appendix A might include information about standard care drugs and symptoms and any drug or device that has been approved and will be used in a conventional way, he says.
Another appendix might provide information about standard clinical care that the participant will receive, including CT scan, radiation treatment, etc., Joffe says.
"These would be included in the appendix rather than up front in the document because they are not relevant to the participant's decision making about being in the study, or else they are less relevant," Joffe says.
Likewise, language required by HIPAA also could be provided in an appendix, Joffe says. "Or you could take the HIPAA language out of the informed consent and make it a separate form," he says.